Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 31bff020-b1f4-4753-9efb-46a6eb1732d8
Route
TOPICAL
Published
Effective Date 2016-03-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg)
Inactive Ingredients
Water Sodium C14-16 Olefin Sulfonate Cocamidopropyl Betaine Glycerin Sodium Chloride Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Cocamidopropyl Pg-dimonium Chloride Phosphate Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600000 Mw) Pummelo Chamaemelum Nobile Flower Green Tea Leaf Chondrus Crispus Neopentyl Glycol Dicaprylate/dicaprate Ascorbyl Palmitate Propylene Glycol C12-15 Alkyl Lactate Polysorbate 20 Butylene Glycol Polyvinyl Alcohol Edetate Disodium Sodium Hydroxide Benzalkonium Chloride Sodium Benzotriazolyl Butylphenol Sulfonate Agar Mannitol Powdered Cellulose .alpha.-tocopherol Acetate Hypromelloses Titanium Dioxide Ferric Oxide Red Mica D&c Red No. 30 Fd&c Red No. 40 Ext. D&c Violet No. 2

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-03-16
Description

Salicylic Acid 2.0%

Purpose

Acne Treatment

Medication Information

Purpose

Acne Treatment

Description

Salicylic Acid 2.0%

Uses

For the treatment of acne.

Warnings

For external use only.

Directions
  • Use daily in the shower or bath. Gently massage on wet skin with washcloth or body puff, concentrating on areas prone to breakouts. Rinse thoroughly.
Label Copy

Active Ingredient

Salicylic Acid 2.0%

Other Information
  • Store between 20°C-25°C (68-77°F)
Questions/comments?

1-800-925-4733

Inactive Ingredients

Water (Aqua), Sodium C14-16 Olefin Sulfonate, Sodium Chloride, Cocamidopropyl Betaine, Glycerin, Acrylates Crosspolymer-4, Cocamidopropyl PG-Dimonium Chloride Phosphate, Polyquaternium-7, Citrus Grandis (Grapefruit) Fruit Extract, Anthemis Nobilis Flower Extract, Camellia Sinensis Leaf Extract, Chondrus Crispus (Carrageenan) Powder, Neopentyl Glycol Dicaprylate/Dicaprate, Ascorbyl Palmitate, Propylene Glycol, C12-15 Alkyl Lactate, Polysorbate 20, Butylene Glycol, Polyvinyl Alcohol, Disodium EDTA, Sodium Hydroxide, Benzalkonium Chloride, Sodium Benzotriazolyl Butylphenol Sulfonate, Agar, Mannitol, Cellulose, Tocopheryl Acetate, Hydroxypropyl Methylcellulose, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491), Mica, Red 30 (CI 73360), Red 40 (CI 16035), Ext. Violet 2 (CI 60730), Fragrance (Parfum).

When Using This Product
  • avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Keep Out of Reach of Children.
  • In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.
Stop Using This Product and Ask A Doctor If
  • irritation or redness develops and lasts.
Ask Doctor Or Pharmacist Before Use If You Are
  • using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless otherwise directed by a doctor.

Structured Label Content

Uses

For the treatment of acne.

Purpose

Acne Treatment

Warnings

For external use only.

Directions
  • Use daily in the shower or bath. Gently massage on wet skin with washcloth or body puff, concentrating on areas prone to breakouts. Rinse thoroughly.
Label Copy

Active Ingredient (Active ingredient)

Salicylic Acid 2.0%

Other Information (Other information)
  • Store between 20°C-25°C (68-77°F)
Questions/comments?

1-800-925-4733

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Sodium C14-16 Olefin Sulfonate, Sodium Chloride, Cocamidopropyl Betaine, Glycerin, Acrylates Crosspolymer-4, Cocamidopropyl PG-Dimonium Chloride Phosphate, Polyquaternium-7, Citrus Grandis (Grapefruit) Fruit Extract, Anthemis Nobilis Flower Extract, Camellia Sinensis Leaf Extract, Chondrus Crispus (Carrageenan) Powder, Neopentyl Glycol Dicaprylate/Dicaprate, Ascorbyl Palmitate, Propylene Glycol, C12-15 Alkyl Lactate, Polysorbate 20, Butylene Glycol, Polyvinyl Alcohol, Disodium EDTA, Sodium Hydroxide, Benzalkonium Chloride, Sodium Benzotriazolyl Butylphenol Sulfonate, Agar, Mannitol, Cellulose, Tocopheryl Acetate, Hydroxypropyl Methylcellulose, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491), Mica, Red 30 (CI 73360), Red 40 (CI 16035), Ext. Violet 2 (CI 60730), Fragrance (Parfum).

When Using This Product (When using this product)
  • avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Keep Out of Reach of Children. (Keep out of reach of children.)
  • In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.
Stop Using This Product and Ask A Doctor If (Stop using this product and ask a doctor if)
  • irritation or redness develops and lasts.
Ask Doctor Or Pharmacist Before Use If You Are (Ask doctor or pharmacist before use if you are)
  • using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless otherwise directed by a doctor.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:05.583959 · Updated: 2026-03-14T22:54:18.927073